Laboratory Manager Design Verification and Validation R and D
Company: Medline Industries, Inc.
Posted on: January 15, 2022
Medline Industries, LP has an immediate opening for a Laboratory
Manager - Design Verification and Validation. This position will be
responsible for managing the daily operations and staff of the
Medline corporate Design Verification and Validation Laboratory
(Mundelein Il). This position will manage a team of engineers and
laboratory technicians that are responsible for performing
mechanical and electrical design verification testing in support of
New Product Development (NPD) and Sustaining projects across all of
Medline%26rsquo;s product divisions.
Manage day to day laboratory activities, develop and organize
testing schedules, and coordinate verification and validation
resources and lab capacity. Ensure priorities and objectives are
communicated clearly; projects are completed on time, and
compliance with protocols and overall objectives.
Coordinate with project teams and R&D management to establish
Verification/Validation plans in support of NPD and Sustaining
Ensure equipment is functioning properly, calibrated, and all
associated documentation is in order.
Oversee the creation, review, approval, and execution of laboratory
policies, procedures, and method validations.
Review documentation produced in the laboratory is ensure
compliance with applicable cGxPs.
Prepares for and participate in internal and external audits by
regulatory authorities (FDA, EU, ISO) and customers.
Responsible for the safety of laboratory personnel/visitors.
Fosters and maintains positive relationships with internal and
external colleagues ensuring timely and accurate communication.
Management responsibilities include: Oversee a team of engineers
(direct management) and laboratory technicians (indirect via
Day-to-day operations of laboratory employees;
Team budgetary responsibility;
Interpret and execute policies for departments/projects;
Recommend and implement new policies or modifications to existing
Provide general guidelines and parameters for staff functioning;
Hiring staff, recommending pay increases, performing performance
reviews, training and development of staff, estimating personnel
needs, assigning work, meeting completion dates, interpreting and
ensuring consistent application of organizational policies.
Please be aware that Medline requires all employees starting in
this position to be fully vaccinated against COVID-19. This
position will require the successful candidate to provide proof
that they are fully vaccinated by their start date. Medline is an
equal opportunity employer, and will provide reasonable
accommodations to those individuals who are unable to be vaccinated
for COVID-19 consistent with federal, state, and local law.
Bachelor%26rsquo;s degree in Engineering
At least 4 years experience with medical device verification and
At least 2 years of leadership responsibility (managing directly)
Experience assessing and initiating actions independently and
acting as project manager.
Experience using time management skills such as prioritizing,
organizing, and tracking details.
Experience applying knowledge of ISO 17025 and CFR requirements;
experience interacting with FDA/ISO auditors.
Experience applying knowledge and experience working with
USP/ASTM/ISO/AAMI/etc test methods.
Experience applying knowledge of FDA/EU MDR requirements and
experience with regulatory interactions as part of medical device
regulatory approval process.
Experience working with medical device design controls and
development processes as defined by ISO 13485 and 21 CFR Part
Statistics Experience with basic hypothesis testing and Design of
Experiments (DOE) preferred.
Demonstrated ability to control and coordinate concurrent projects,
competing priorities, and critical deadlines.
Technical writing skill and ability.
Skill and ability to diagnose, isolate, and resolve complex issues
and recommend and implement strategies to resolve problems.
Ability to present and communicate with various audiences (e.g.
senior management and non-technical audiences).
Keywords: Medline Industries, Inc., Arlington Heights , Laboratory Manager Design Verification and Validation R and D, Healthcare , Mundelein, Illinois
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